CN115209940B - Carrier element for microneedles and microneedle array device - Google Patents
Carrier element for microneedles and microneedle array device Download PDFInfo
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- CN115209940B CN115209940B CN202180017816.3A CN202180017816A CN115209940B CN 115209940 B CN115209940 B CN 115209940B CN 202180017816 A CN202180017816 A CN 202180017816A CN 115209940 B CN115209940 B CN 115209940B
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- 229920006280 packaging film Polymers 0.000 claims description 16
- 239000012785 packaging film Substances 0.000 claims description 16
- 238000004806 packaging method and process Methods 0.000 claims description 15
- 239000000853 adhesive Substances 0.000 claims description 11
- 230000001070 adhesive effect Effects 0.000 claims description 11
- 235000001674 Agaricus brunnescens Nutrition 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 239000007788 liquid Substances 0.000 description 31
- 239000004480 active ingredient Substances 0.000 description 19
- 239000000463 material Substances 0.000 description 12
- 238000004519 manufacturing process Methods 0.000 description 9
- 238000003491 array Methods 0.000 description 6
- 239000010410 layer Substances 0.000 description 4
- 239000002904 solvent Substances 0.000 description 3
- 238000010521 absorption reaction Methods 0.000 description 2
- 210000004204 blood vessel Anatomy 0.000 description 2
- 238000005266 casting Methods 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 210000005036 nerve Anatomy 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000037317 transdermal delivery Effects 0.000 description 2
- 239000011358 absorbing material Substances 0.000 description 1
- 230000004308 accommodation Effects 0.000 description 1
- 239000002313 adhesive film Substances 0.000 description 1
- 239000012790 adhesive layer Substances 0.000 description 1
- 238000009455 aseptic packaging Methods 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000012876 carrier material Substances 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 210000005081 epithelial layer Anatomy 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000007373 indentation Methods 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
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- 238000007789 sealing Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/06—Packaging for specific medical equipment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/08—Supports for equipment
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Knitting Machines (AREA)
Abstract
A carrier element for forming microneedles of a microneedle array has a plate-like base element (10). A mounting element (14) for connection to the microneedles (32) of the microneedle array, respectively, is provided on the front side (12) of the base element (10). Connection elements (16, 36) are also provided, in particular on the front side (18) of the mounting element (14). The connecting elements (16, 36) are formed in the following manner: they have an undercut in the longitudinal direction (22) so that the needle (32) is reliably connected to the mounting element (14).
Description
[ field of technology ]
The present invention relates to a carrier element for forming a microneedle array or microneedle of a microneedle array device. The invention also relates to a microneedle array device.
[ background Art ]
Microneedles are used to deliver active ingredients directly into the skin, also known as transdermal delivery (transdermal delivery). For this reason, the length of the microneedle is just sufficient to penetrate only the outer skin layer, but preferably does not reach the nerve and blood vessel, thereby leaving the nerve and blood vessel undamaged. However, microneedles create small holes in the epithelial layer that significantly increase the absorption of the active ingredient compared to pure external application of the active ingredient to the skin.
The microneedle array has, for example, a plurality of microneedles attached to a carrier surface, and may be used for short-term delivery or long-term administration. The preferred way of delivering the active ingredient from the microneedle into the skin is for the microneedle area or the entire microneedle containing the active ingredient to dissolve or separate and thereby be absorbable by the body through the skin. For this purpose, the microneedles are in particular made at least partially of a water-soluble substance or material, respectively. In addition to delivering the active ingredient directly through the microneedle itself, the microneedle may also have apertures or cavities or be formed as a hollow needle to enable delivery of the active ingredient into the skin in this manner. In addition, the microneedles may also be free of active ingredients. In this case, for example, the active ingredient may be externally applied to the outside of the microneedle, or the active ingredient-containing substance may be applied to the corresponding skin region only after the microneedle is removed from the skin, so that the active ingredient is delivered using the microneedle in this way.
The microneedles may be made of ceramic, metal or polymer, as well as other materials. Preferably, one or more active ingredient components are added to these materials, thereby producing a microneedle formulation.
Previously known methods for manufacturing therapeutic or diagnostic microneedles or microneedle arrays, respectively, are unsuitable or only to a limited extent suitable for manufacturing with sufficient quality and/or quantity.
Common methods of manufacturing microneedles include, for example, casting the microneedles or the entire microneedle array, respectively, using a casting mold (such as a mold (die) made of silicone). In particular, there are a number of problems in this manufacturing method due to the hydrophobicity between the mould and the normally liquid formulation applied thereto.
Typically, two or more liquids are used to fabricate the microneedle array. First, a first liquid or formulation with an active ingredient is dosed onto a (dosed onto) mold such that the recesses forming the microneedles are partially filled with the first liquid. After this first liquid has dried, a second liquid, generally free of active ingredient, is dosed onto the mould so that, on the one hand, the recesses are completely filled and a closed covering of the interconnected needles is produced. In this case, the problem arises that the two liquids are mixed with one another, since the second liquid must at least partially dissolve the first liquid, or the first liquid must not yet be completely dried in order to ensure a combination of the two liquids. In particular, migration of the active ingredient into the second or lower layer may occur, such that the availability of the active ingredient is reduced. Moreover, there are substantial disadvantages in that a long drying process is required.
For percutaneous administration of microneedles, a microneedle array is typically placed on the skin and the needles are applied by applying uniform pressure on the back side of the microneedle array. In such manual applications, it is extremely difficult to apply a uniform and unidirectional force on all the needles.
Further, mechanical applicators (mechanical applicator) for applying microneedle arrays are known. For such applicators, the microneedle array must first be placed on the applicator using an adhesive film. This is also difficult and may cause damage to the individual needles.
Moreover, packaging is a problem with microneedle arrays because microneedle arrays must be packaged individually, often in a sterile manner. This is generally done using blisters (blister, i.e. especially transparent packaging films). In order to meet the requirements regarding sterility, it is necessary to weld or seal the blister. Sealing on the adhesive layer requires a great deal of effort. In particular, not all adhesives are suitable for this.
A carrier element for microneedles forming a microneedle array is known from EP 3 459 584. Such a carrier element has a plate-like base element. A mounting element is provided on the front side of the base element. Here, the front side of the base element is the side facing the microneedles. The mounting member is formed in a truncated cone shape and has a front side on which conical microneedles are arranged. For manufacturing microneedle arrays, it is known from EP 3 459 584 to dose a first liquid with an active ingredient into a conical recess of a mould. Here, the volume of the fluid is selected such that the individual frustoconical recesses forming the microneedles are not completely filled. In a next step, the carrier element is placed on the mold such that the frustoconical mounting element protrudes into the recess and a connection is made between the front side of the mounting element and the material forming the microneedles. Although it is known from EP 3 459 548 to provide one or more recesses at the front side of the mounting element, the problem still remains that a single microneedle cannot be reliably connected to the mounting element of the carrier element.
[ invention ]
The object of the invention is to provide a carrier element with which a better connection to the microneedles can be achieved. It is a further object of the present invention, which is independent of the above object, to provide an improved microneedle array device.
This object is achieved by means of a carrier element having the features of claim 1 and a microneedle device having the features of claim 12.
The carrier element for forming microneedles of a microneedle array according to the present invention has a plate-like base element. A mounting element is provided on the front side of the base element. The mounting elements are each adapted to be connected to a particular one of the microneedles of the microneedle array. Thus, when the carrier element is connected with the microneedles, the front side of the base element is the side facing in the direction of the microneedles.
Each mounting element is provided with a connecting element. Such a connecting element is provided in particular on the front side of the mounting element, but may also be provided on the side of the mounting element or on both the side and the front side of the mounting element. In order to achieve a better connection of the microneedles to the mounting element, according to the present invention, the connection is formed such that it has undercuts (undercut) in the longitudinal direction. Here, the longitudinal direction is the center line or symmetry line of each mounting element and the microneedle. Alternatively, the machine direction is the demolding direction, i.e. the direction or axis in which the carrier element is removed from the mold together with the microneedles. Due to the undercut provided according to the invention in the longitudinal direction, the material of the microneedles is at least partly engaged around or behind the mounting elements or the connecting elements provided on the mounting elements. Due to this undercut, a significantly better connection is achieved. Since it is preferred that the mounting element of the carrier element is arranged in the recess of the mould as long as the liquid previously dosed into the recess has not yet solidified or at least has not solidified completely, the liquid reaches the corresponding undercut region in a simple manner.
The connection elements may be protrusions (projections), or the connection elements may have protrusions, wherein it is of course possible that the carrier element has different connection elements and/or a combination of different connection elements on different mounting elements. In the case of the connecting elements being formed as projections, these extend in the longitudinal direction and form undercuts in the preferred embodiment. This is achieved in particular by the cross section of the protrusions tapering in the longitudinal direction; i.e. starting from the microneedle, the projection tapers towards the front side of the base element, i.e. in particular in the longitudinal direction.
To taper the cross section, the protrusions preferably comprise grooves (grooves). The recess may be circumferential and is thus formed in particular annularly (annular). Thus, in a side view, it is particularly preferable that the protrusion is formed in a mushroom shape (a mushroom shape). The projection thereby comprises a cylindrical web having a cross section, in particular circular or polygonal. The web is connected to an enlarged portion, such as a head portion.
In a further preferred embodiment, the connection element is formed as a recess (recess), a transverse bore (transversal bores) or the like in the mounting element. Providing recesses, transverse holes, etc. that do not extend at least partially in the longitudinal direction has led to the formation of undercuts. During manufacture, at least still tacky material of the microneedles enters these recesses, transverse holes, etc. After curing, a particularly rigid connection is formed which is reliable due to the undercut.
Of course, such connecting elements provided as recesses, transverse bores, etc. can be combined with the above-described connecting elements which are particularly configured as projections.
In a further preferred embodiment, the connecting element is at least partially or completely formed as a channel extending into the mounting element. In particular, the channels are arranged such that they do not extend at least partially into the longitudinal direction or exhibit an angle of ±0° with respect to the longitudinal direction. In this case, it is particularly preferred if the cross section of the channel widens in the longitudinal direction to form an undercut. Such a channel thus preferably extends from the front side of the mounting element towards the front side of the base element and has at least one cross-sectional enlargement in this direction. Thus, undercut is achieved by the material entry channel of the microneedle.
This particular design of the channel with the cross-sectional enlargement can also be combined with the above-described alternative embodiment of the connecting element.
Preferably, the channel or another recess in the mounting element has a volume that is greater than the volume of the liquid from which the microneedle is made, which liquid is typically received during manufacture. Thereby, excess material can be received and a reliable connection can be achieved. If necessary, the channel may extend to the rear side of the base element, so that even a liquid exit is possible.
In a particularly preferred development of the invention, the carrier element is at least partially made of a solvent-absorbing material. Thus, the material is suitable for absorbing solvents present in the liquid forming the microneedles. This is advantageous in that the carrier element can then be inserted into the recess of the mould in a state in which the material forming the needle is still very liquid, since the curing of the material forming the needle is ensured due to the absorption of solvent by the carrier element. In particular, the mounting element of the carrier element comprises such a material.
Since the channel extends to the rear side of the base element and is thus open, there is the further advantage that solvent can escape in a simple manner.
In particular, it is advantageous to provide a holder on the rear side of the base element of the carrier element. Here, the rear side of the base element is opposite to the front side, and when the microneedles are present, the rear side of the base element points away from the microneedles. Such a holder or such a fixation element allows for a simple accommodation of the carrier element by the applicator. For example, the retainer may be a generally cylindrical pin-like protrusion (pin-shaped protrusion). The retainer may have a circumferential groove, for example, to mate with a latching connection (latching connection) on the applicator.
Further, it is preferred that the connection surface is provided in an edge region on the front side and/or the rear side of the base element. In particular, the connection surface is an adhesive surface (adhesive surface). On the adhesive side, a packaging element, in particular a packaging film, such as a blister, may be provided. Thus, the microneedles can be packaged in a simple manner, particularly in a sterile manner. Due to the connection of the packaging element with the carrier element, a simple removal is possible. In particular, the risk of damaging the microneedles is significantly reduced when removed. The edge region is preferably formed circumferentially, in particular in the shape of a frame.
The invention also relates to a microneedle array comprising a carrier element, wherein the carrier element is constructed as described above and is developed in an advantageous manner. The microneedles are provided or arranged at least a portion of the mounting elements, in particular at the respective mounting element. Thus, the present invention relates to microneedle arrays fabricated using the carrier elements described above.
The invention also relates to a microneedle array device. The device comprises a carrier element having at least one plate-like base element and a mounting element arranged on the front side of the base element, each mounting element being intended to be connected with a respective microneedle of the microneedle array. The connecting element described above does not have to be provided, in particular in a preferred development, but it is particularly preferred according to the invention that such a connecting element is provided, in particular, in the embodiment described above. In the microneedle array device according to the present invention, the microneedles are connected to the mounting element. Further, a packaging element is provided by which the microneedles are packaged, in particular in a sterile manner. As described above in relation to the carrier element, the packaging element is preferably arranged in the edge region of the carrier element. The connection is preferably established here via connection surfaces provided on the front side and/or the rear side of the base element of the carrier element.
The packaging element may also be designed such that it comprises a recess (recess). The recess serves for receiving the carrier element, wherein in a preferred embodiment the recess is closed at least on one side, in particular with a packaging film. Preferably, the film is designed such that it can be peeled off. Preferably, a packaging film or the like is disposed on the side on which the microneedles are disposed. Thereby, after removal of the packaging film, the carrier element can be easily pushed out of the recess and in particular the needle is immediately applied.
Alternatively or additionally, the packaging film can also be provided on the opposite side (i.e. in the region of the rear side of the carrier element). This is particularly advantageous when the carrier element has a holder for connection with the applicator. Such a packaging film, in particular also a peelable packaging film, can then be removed, wherein the applicator can be connected to the holder immediately thereafter. Using the applicator, the applicator can then be removed in the direction of the applicator. If the corresponding film is provided on both sides, it is likewise possible to remove the film provided on one side of the microneedle and to use the applicator to move the carrier element in this direction and to apply the microneedle directly.
As mentioned above, the carrier element of the microneedle device is preferably developed in an advantageous manner.
For manufacturing the microneedle array device, a mold having a plurality of special conical depressions (conical indentations) is preferably used. The recesses are used to form microneedles. In a first step, a liquid, in particular a liquid with an active ingredient, is dosed into the recess of the mould. Here, the recess is only partially filled. The carrier element according to the invention is then placed in the recess of the mould, in particular before the liquid has completely dried, so that the mounting element protrudes into the recess and a connection between the liquid and the mounting element is established as a result of the connection of the connecting element with the mounting element. This is achieved in particular in the following way: the liquid is connected to the connecting elements such that these are partially enclosed or joined behind. Thereby, an undercut is formed.
[ description of the drawings ]
The invention is described in more detail below with the aid of preferred embodiments with reference to the accompanying drawings.
In the accompanying drawings:
fig. 1 is a schematic perspective view of a first embodiment of a carrier element, seen from below;
FIG. 2 is a schematic cross-sectional view of the carrier element of FIG. 1 along line II-II;
FIG. 3 is a schematic cross-sectional view of a mold;
fig. 4 is a schematic cross-sectional view of the carrier element of fig. 1 and 2 in combination with the mold of fig. 3;
fig. 5 is a schematic perspective view of a second embodiment of the carrier element seen from below;
fig. 6 is a schematic cross-sectional view of the carrier element of fig. 5 along line VI-VI;
fig. 7 is a schematic cross-sectional view of the carrier element of fig. 5 and 6 in combination with the mold of fig. 3;
fig. 8 is a schematic cross-sectional view of the carrier element of fig. 5 and 6 according to an alternative embodiment;
FIG. 9 is a schematic side view of a further embodiment of a carrier element;
fig. 10 shows a first preferred embodiment of a microneedle array device based on the carrier element of fig. 9;
FIG. 11 shows a second preferred embodiment of a microneedle array device based on the carrier element of FIG. 9; and
fig. 12 shows a third preferred embodiment of a microneedle array device based on the carrier element of fig. 9.
[ detailed description ] of the invention
The first embodiment of the carrier element (fig. 1 and 2) comprises a plate-like base element 10. A plurality of frusto-conical mounting elements 14 are arranged on the front side 12 of the base element 10. In the illustrated embodiment, only 9 such mounting elements are illustrated for clarity.
In the illustrated embodiment, each mounting member 14 includes a connecting member 16. In the first embodiment, the connecting element 16 is designed as a channel extending from the front side 18 of the mounting element to the rear side 20 of the base element. In a first portion 24 of the channel 16 extending in the longitudinal direction 22, the channel has a smaller diameter than in a second portion 26. Due to the different cross-sections in the sections 24 and 26 of the channel 16, an undercut is formed.
Mold 28 (fig. 3) is used to fabricate the microneedle array. The mold 28 has a plurality of conical depressions 30. The arrangement and number of conical depressions 30 corresponds to the arrangement and number of mounting elements 14.
First, the recess 30 is partially filled with a liquid 32. Here, the liquid 32 containing the active ingredient is dosed such that the recess 30 is only partially filled.
In a next step, the carrier material is placed on the upper surface 34 of the mould 32 such that the front side 12 of the base element 10 rests on the upper surface 34 (see fig. 4). In this case, the mounting element 14 is arranged in the recess 30, wherein the liquid 32 penetrates into the channel 16, in particular into the first channel portion 24. A portion of the liquid also penetrates the channel portion 26 so that an undercut is formed (as can be seen in fig. 4). When the carrier element is released in the longitudinal or release direction 22, it is thereby ensured that the liquid microneedle-forming portions 22 remain fixedly connected with the mounting element 14 due to the undercut.
In the second embodiment described with reference to fig. 5 to 7, similar and identical components are identified by identical reference numerals.
In a second preferred embodiment, the connecting element 36 is arranged as a connecting element on the front side 18 of the mounting element 14. The connecting element 36 is designed as a mushroom-shaped projection in cross section. The projection 36 thus has, in particular, an annular groove 38 in the longitudinal or demolding direction 22. The recess 38 forms an undercut with respect to the head element 40 of the projection 36.
The manufacture of the carrier element with the microneedles is correspondingly carried out as described above with reference to the first embodiment and figures 3 and 4. As can be seen in fig. 7, the liquid 32 surrounds the protrusions 36, so that a firm, in particular rigid, connection between the mounting element 14 and the liquid 32 forming the needle is achieved due to the undercut.
Fig. 8 illustrates an alternative embodiment to the embodiment illustrated in fig. 5-7. The connecting elements are of identical design. The only difference is that the mounting element 14 includes a longer shaft 42 such that the front side 12 of the base element 10 is spaced from the upper surface 34 of the mold 28. Thus, needles of different lengths can be manufactured in a simple manner while using the same mold 28.
Fig. 9 illustrates a modification of the second embodiment illustrated in fig. 5 to 7. Here, a holder 34 is provided on the rear side 20 of the base element 10. In the illustrated embodiment, the retainer 44 is formed in a cylindrical shape and has an annular groove 46. The carrier element may be connected to the applicator via a retainer 44. For example, a secure fixation may be achieved by a latching connection that latches into the recess 46.
Of course, the holder 44 may also be arranged on the rear side of the first embodiment illustrated in fig. 1 to 4.
Fig. 10 to 12 show different embodiments of microneedle array devices based on carrier elements with holders 44 as illustrated in fig. 9.
For aseptic packaging, the embodiment illustrated in fig. 10 is provided with a connecting surface 50 in the edge region 48 on the front side 12 of the base element 10. In particular, the connection surface 50 is an adhesive surface (adhesive surface). The connection surface 50 is arranged circumferentially on the front side 12 of the base element 10 and thereby encloses the mounting element 14 in a frame-shaped manner. The microneedle array, i.e., particularly the area in contact with the patient, can be easily packaged in a sterile manner using a packaging film 52 disposed on the adhesive side 50.
An alternative packaging option is illustrated in fig. 11. In this embodiment, the corresponding packaging element 54, again embodied in particular as a film, extends around the edge region of the base element 10. On the rear side 20, the connection layer 50 is again arranged in the edge region 48. The connection layer is also particularly formed in the shape of a frame and encloses the entire base element 10.
In the embodiment illustrated in fig. 12, the carrier element is arranged in an additional package 46 together with the needle 32 formed of liquid. The additional package 56 has a recess or opening 58 in which, in particular, the base element 10 of the carrier element is arranged. In the illustrated embodiment, the recess is closed on the side of the microneedle 32 by a packaging film 60 fastened on the outside of the additional package by an adhesive face 50. Opposite thereto, a further packaging film 62 is provided, which has an adhesive surface 50 on the outside of the additional package 56.
The additional package illustrated in fig. 12 provides protection for the entire carrier element including the retainer 40 arranged on the rear side 20 of the base element 10. The carrier element itself can be held in the opening 58 of the additional package 56 by means of a locking hook, a mounting element or the like. Thus, the carrier element can be easily held in a defined position until a force is applied, for example by the applicator via the holder 44.
In the illustrated embodiment, a groove having a semicircular cross section may be provided on the outside of the package 56. Thus, the entire additional package 56 may be installed in or received in the applicator. All that is required for application is then to remove the packaging film 60.
Claims (17)
1. A carrier element for forming microneedles of a microneedle array, comprising:
-a plate-like base element (10);
-mounting elements (14) provided on the front side (12) of the base element (10), each mounting element being for connection to one microneedle (32) of the microneedle array; and
a connecting element (16, 36) which is arranged on the front side (18) of the mounting element (14),
it is characterized in that the method comprises the steps of,
the connecting element (16, 36) has an undercut in the longitudinal direction (22), the connecting element (36) at least partially comprising a projection extending along the longitudinal direction (22), the projection comprising a circumferential groove (38) for forming a cross-sectional cone.
2. Carrier element for forming microneedles of a microneedle array according to claim 1, characterized in that the protrusions comprise the cross-sectional taper transverse to the longitudinal direction (22) in order to form the undercut.
3. Carrier element for forming microneedles of a microneedle array according to any one of claims 1-2, characterized in that the protrusions are formed in a mushroom shape.
4. The carrier element for forming microneedles of one of claims 1-2, characterized in that the connecting element (16) comprises at least partially one or more channels (24, 26) extending into the mounting element (14).
5. The carrier element for forming microneedles of a microneedle array according to claim 4, characterized in that the channels (24, 26) do not extend at least partially in the longitudinal direction (22).
6. Carrier element for forming microneedles of a microneedle array according to claim 4, characterized in that the channels (24, 26) exhibit at least partially a cross-sectional enlargement for forming an undercut.
7. The carrier element for forming microneedles of a microneedle array according to claim 4, characterized in that the channels (24, 26) extend at least partially towards the front side (12) of the base element (10) starting from the front side (18) of the mounting element (14).
8. The carrier element for forming microneedles of a microneedle array according to claim 4, characterized in that the channels (24, 26) extend at least partially from the front side (18) of the mounting element (14) towards the rear side (20) of the base element (10).
9. Carrier element for forming microneedles of a microneedle array according to any one of claims 1-2, characterized in that a holder (44) for holding the carrier element by an applicator is provided on the rear side (20) of the base element (10).
10. Carrier element for forming microneedles of a microneedle array according to claim 9, characterized in that a connection face (50) is provided in an edge area (48) on the front side (12) and/or the rear side (20) of the base element (10), which connection face (50) is an adhesive face for a packaging element (52, 54), which packaging element is a packaging film.
11. A microneedle array having a carrier element according to any one of claims 1 to 10 and microneedles (32) provided at respective mounting elements (14).
12. A microneedle array device comprising:
a carrier element for forming microneedles of a microneedle array, comprising:
-a plate-like base element (10);
-mounting elements (14) provided on the front side (12) of the base element (10), each mounting element being for connection to one microneedle (32) of the microneedle array;
-a connecting element (16, 36) provided on the front side (18) of the mounting element (14), the connecting element (16, 36) having an undercut in the longitudinal direction (22), the connecting element (36) at least partially comprising a projection extending along the longitudinal direction (22), the projection comprising a circumferential groove (38) for forming a cross-sectional cone;
a microneedle (32) connected with the mounting element (14); and
-a packaging element (52, 54;56, 60, 62) for packaging at least the microneedles (32) in a sterile manner.
13. Microneedle array device according to claim 12, characterized in that a connection face (50) is provided in an edge region (48) on the front side (12) and/or the rear side (20) of the base element (10), which connection face (50) is an adhesive face for a packaging element (52, 54), which packaging element is a packaging film.
14. Microneedle array device according to claim 12 or 13, characterized in that the packaging element (56, 60, 62) comprises a recess (58) for receiving the carrier element, which recess (58) is closed at least on one side with a packaging film (60, 62), which is peelable.
15. Microneedle array device according to claim 14, characterized in that the packaging film is provided at least on the sides of the microneedles (32).
16. Microneedle array device according to claim 15, characterized in that a holder (44) for holding the carrier element by an applicator is provided on the rear side (20) of the base element (10).
17. Microneedle array device according to claim 12, characterized in that a holder (44) for holding the carrier element by an applicator is provided on the rear side (20) of the base element (10).
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE102020109157.5A DE102020109157A1 (en) | 2020-04-02 | 2020-04-02 | Carrier element for microneedles as well as microneedle array device |
| DE102020109157.5 | 2020-04-02 | ||
| PCT/EP2021/056687 WO2021197836A2 (en) | 2020-04-02 | 2021-03-16 | Carrier element for micro-needles, and micro-needle array device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN115209940A CN115209940A (en) | 2022-10-18 |
| CN115209940B true CN115209940B (en) | 2024-01-30 |
Family
ID=75111577
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202180017816.3A Active CN115209940B (en) | 2020-04-02 | 2021-03-16 | Carrier element for microneedles and microneedle array device |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US20230146417A1 (en) |
| EP (1) | EP4126180A2 (en) |
| JP (1) | JP2023519222A (en) |
| CN (1) | CN115209940B (en) |
| BR (1) | BR112022016665A2 (en) |
| CA (1) | CA3173523A1 (en) |
| DE (1) | DE102020109157A1 (en) |
| WO (1) | WO2021197836A2 (en) |
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2020
- 2020-04-02 DE DE102020109157.5A patent/DE102020109157A1/en active Pending
-
2021
- 2021-03-16 US US17/916,290 patent/US20230146417A1/en active Pending
- 2021-03-16 WO PCT/EP2021/056687 patent/WO2021197836A2/en unknown
- 2021-03-16 JP JP2022556658A patent/JP2023519222A/en active Pending
- 2021-03-16 CA CA3173523A patent/CA3173523A1/en active Pending
- 2021-03-16 BR BR112022016665A patent/BR112022016665A2/en unknown
- 2021-03-16 EP EP21713349.5A patent/EP4126180A2/en active Pending
- 2021-03-16 CN CN202180017816.3A patent/CN115209940B/en active Active
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Also Published As
| Publication number | Publication date |
|---|---|
| EP4126180A2 (en) | 2023-02-08 |
| WO2021197836A2 (en) | 2021-10-07 |
| DE102020109157A1 (en) | 2021-10-07 |
| JP2023519222A (en) | 2023-05-10 |
| BR112022016665A2 (en) | 2022-10-11 |
| CA3173523A1 (en) | 2021-10-07 |
| US20230146417A1 (en) | 2023-05-11 |
| CN115209940A (en) | 2022-10-18 |
| WO2021197836A3 (en) | 2022-01-13 |
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